High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 17, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
"Immunization; InfectionInfluenza
Interventions
BIOLOGICAL

Fluzone High Dose Inactivated Influenza Vaccine

Fluzone High-Dose (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus- containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a split virus. The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation.

BIOLOGICAL

Fluzone Standard Dose Inactivated Influenza Vaccine

Fluzone Standard Dose is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.

Trial Locations (1)

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER

NCT07192458 - High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater) | Biotech Hunter | Biotech Hunter